Catalog Number SGC0702 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Low Blood Pressure/ Hypotension (1914); Tachycardia (2095); Pericardial Effusion (3271)
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Event Date 12/13/2021 |
Event Type
Injury
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Manufacturer Narrative
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The device will not be returned for evaluation, the device was reportedly discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
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Event Description
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It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 4.The clip delivery system (cds) was advanced, and the clip was implanted successfully reducing mr to 1.When the steerable guide catheter was withdrawn to the right atrium, the patient's blood pressure dropped and tachycardia occurred.Echocardiogram showed a moderate to severe pericardial effusion.Medication was given and pericardiocentesis was performed successfully, and the patient was transferred to intensive critical care unit.The patient was reported to be doing well.No additional information was provided.
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Manufacturer Narrative
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The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Based on the available information, a cause for the reported hypotension and pericardial effusion could not be determined.The reported tachycardia was due to reported hypotension.The reported patient effects of hypotension, pericardial effusion and tachycardia are listed in the instruction for use (ifu) as known possible complications associated with mitraclip procedures.The reported medical intervention, hospitalization and required medication was a result of case specific circumstances.There is no indication of a product issue with respect to manufacture, design or labeling.E1.Initial reporter.
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Search Alerts/Recalls
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